Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training

Body Weight Changes Clinical Trial

Official title:

Effect of the Administration of L-Carnitine on Body Fat Percentage and Body Weight in Overweight Women in Crossfit Training.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03436277
• Other study ID #: LC-CUT-DMHC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 11, 2018
• Last updated: February 18, 2018
• Start date: December 17, 2018
• Est. completion date: May 2019

Study information

• Verified date: February 2018
• Source: University of Guadalajara
• Contact: Diana M Hernández, PhD
• Phone: +521 3314856584
• Email: diana.hcorona[@]academicos.udg.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The L-carnitine has demonstrated effects in the treatment of obesity mainly promoting the fat degradation during exercise.

Description:

A randomized, double-blind, placebo-controlled clinical trial will be carry out in 24 woman with body mass index ≥ 25 to 29.9 kg/m2. The patients will receive 1.5 g of L-Carnitine deluded in 250 ml of water or placebo before crossfit training, 5 times a week for 8 weeks. Before and after intervention the investigators evaluate: The body composition (body fat, lean body mass), arm muscle circumference, waist circumference, body weight and body mass index.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Volunteers who practice crossfit regularly (who have 3 months prior to the beginning of the study practicing crossfit).

• Volunteers with a body mass index equal to or greater than 25 Kg/m2.

• Volunteers who do not have allergies to L-Carnitine or any of its components.

• Informed consent signed

• Women with a recommendation of nutrition two weeks prior to the start of the study.

• Body weight stable the last 3 months.

Exclusion Criteria:

• Volunteers with pathologies such as diabetes, hypertension, metabolic syndrome and allergies.

• Women with confirmed or suspected pregnancy.

• Women under lactation and/or puerperium.

• Hypersensibilility to L-Carnitine or Sucralose.

• Kown of renal, hepatic or thyroid deseased.

• Current or previous treatment diet (3 months before inclusion to the study).

• Current pharmacological treatment for loose body weight or 3 months before inclusion to the study.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes

Intervention

Drug:
• L-Carnitine
L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks

Dietary Supplement:
• Sucralose
Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks

Locations

Country	Name	City	State
Mexico	Centro Universitario de Tonalá	Tonalá	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Behrend AM, Harding CO, Shoemaker JD, Matern D, Sahn DJ, Elliot DL, Gillingham MB. Substrate oxidation and cardiac performance during exercise in disorders of long chain fatty acid oxidation. Mol Genet Metab. 2012 Jan;105(1):110-5. doi: 10.1016/j.ymgme.2011.09.030. Epub 2011 Oct 1. — View Citation

Broad EM, Maughan RJ, Galloway S DR. Effects of exercise intensity and altered substrate availability on cardiovascular and metabolic responses to exercise after oral carnitine supplementation in athletes. Int J Sport Nutr Exerc Metab. 2011 Oct;21(5):385-97. Epub 2011 Aug 3. — View Citation

Hongu N, Sachan DS. Carnitine and choline supplementation with exercise alter carnitine profiles, biochemical markers of fat metabolism and serum leptin concentration in healthy women. J Nutr. 2003 Jan;133(1):84-9. — View Citation

Huang A, Owen K. Role of supplementary L-carnitine in exercise and exercise recovery. Med Sport Sci. 2012;59:135-42. doi: 10.1159/000341934. Epub 2012 Oct 15. — View Citation

Kraemer WJ, Spiering BA, Volek JS, Ratamess NA, Sharman MJ, Rubin MR, French DN, Silvestre R, Hatfield DL, Van Heest JL, Vingren JL, Judelson DA, Deschenes MR, Maresh CM. Androgenic responses to resistance exercise: effects of feeding and L-carnitine. Med Sci Sports Exerc. 2006 Jul;38(7):1288-96. Erratum in: Med Sci Sports Exerc. 2006 Oct;38(10):1861. — View Citation

Villani RG, Gannon J, Self M, Rich PA. L-Carnitine supplementation combined with aerobic training does not promote weight loss in moderately obese women. Int J Sport Nutr Exerc Metab. 2000 Jun;10(2):199-207. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Fat	Calulated by Durnin formula. Results are reported in percentage and kg	8 weeks
Primary	Lean body mass	Calulated by Durnin formula. Results are reported in percentage and kg	8 weeks
Primary	Body Weight	Subject go up onto the scale and stand still over the center of the scale with body weight evenly distributed between both feet. Omron hbf-514c an digital scale and results are reported in kg with a decimal.	8 weeks
Secondary	Arm muscle circumference	The right arm measure to the nearest centimeter with a measuring tape. Then, triceps skinfold thickness, an established measure of fat stores, measure to the nearest millimeter in the right arm using a skinfold caliper	8 weeks
Secondary	Waist circumference	Flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.; Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.; Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.	8 weeks
Secondary	Body Mass Index	Body mass divided by the square of the body height, and reported in units of kg/m2.	8 weeks